A variety of techniques have been developed for processing, packaging, and storing food products. Among these techniques are freezing, canning, irradiation, and drying. More recently, food products are being packaged and stored by an aseptic packaging procedure. Aseptic packaging allows food products to be stored at room temperature for extended periods of time without spoiling or degradation of the food product.
Generally, during aseptic processing, the food product is sterilized to destroy any sources of decay such as thermophilic spores or other pathogens. The food product is then placed in sterilized protective packaging. The process and equipment used during aseptic packaging must also remain sterile so as not to contaminate the food product or the packaging material. The packaging material, once sealed around the sterilized food product, provides a barrier against any later possible invasion by harmful organisms or pathogens, and therefore provides a commercially sterile food product. Aseptic packaging provides a packaged food product having a shelf life of 150 days or more.
In the United States, the aseptic processing of food products is regulated by the U.S. Food and Drug Administration (“FDA”). The FDA categorizes food products as either high acid products, having a pH below 4.6, or low acid products, having a pH above 4.6. The acid content of high acid food products helps to reduce the microbial population in the food product and also inhibits the growth of microorganisms. However, low acid food products do not provide this anti-bacterial environment, and accordingly, the FDA regulations for the aseptic processing and packaging of low acid foods are more stringent.
As such, while blow fill seal processes have gained wide acceptance in the pharmaceutical industry and for high acid foods, due to strict sterility requirements, low acid foods are generally not aseptically packaged by blow-fill seal operations.
During the blow fill seal process/operation a container is formed, filled with the desired product, and sealed in a continuous process without human intervention, in an enclosed area or environment inside a machine. Typically, blow-fill seal processes carry out both the forming of the primary package and the subsequent filling operation. The enclosed stationary sterile area where the forming of the package and the filling occurs is often referred to as an aseptic work zone (“AWZ”). Typically, the aseptic work zone is the area(s) of a filling operation where the sterile package and sterile product are combined. Thus in many blow-fill-seal fillers the aseptic work zone can be quite large. Further, in many conventional blow-fill seal processes the aseptic work zone is a stationary area that is sterilized. The blow-fill seal operation maintains an aseptically sterile work zone for the aseptic processing of food products.
Further, in conventional blow-fill seal aseptic operations the aseptic work zone includes product contact surfaces which are pre-sterilized and the filling area, which includes the entire area under a shroud where the filling occurs. In conventional blow-fill seal operations, the area under the shroud is not currently pre-sterilized. However, HEPA-filtered air is used to provide sterile filtered air in the filling zone within the blow-fill seal machine. Pressure differentials are used within the room containing the blow-fill seal machine and between the area where the parison is formed and the filling area. Accordingly, sterility maintenance is achieved through use of sterile-filtered air, HEPA-filtered air, and pressure differentials for the rest of the machine.
The use of blow fill seal technology has come under scrutiny from regulatory authorities, such as the U.S. Food and Drug Administration. There are concerns surrounding the possibility of product contamination by airborne particles, and in particular viable microorganisms, which have led to debate about the quality of the environment where filling and sealing of the blow-fill seal containers and/or packages occurs.
Thus, given these sterility concerns, the need for high volume product output, and low operation costs, there exists a need for improved blow-fill seal processes over conventional blow-fill seal processes. Additionally, the aseptic work zone of conventional blow-fill seal machines do not meet the sterility standards established by the FDA for the packaging of low acid food products.
Accordingly, this disclosure is directed to an aseptic work zone using blow-fill-seal aseptic packaging that satisfies the regulatory requirements for aseptic filling of low-acid foods. Moreover, the disclosure is directed to methods of maintaining sterility of the aseptic work zone, such that low acid foods may be aseptically packaged in accordance with FDA standards. The methods disclosed herein further include an aseptic work zone that is mobile. Additionally, the disclosure is directed to methods of maintaining the sterility of the aseptic work zone during multiple blow-fill seal cycles, such that the blow fill seal operation does not have to take place in an enclosed environment. Further provided herein are methods for forming a hermetically sealed container that includes a sterile low-acid food product.